Orthopedic Device Approval Testing
The Applied Technical Services Family of Companies (FoC) offers orthopedic device approval testing for the manufacturers of orthopedic devices. Manufacturers design orthopedic devices to prevent and treat musculoskeletal disorders, diseases, injuries, and conditions. Technological advancement has led to improved medical outcomes for orthopedic medical device users worldwide and while medical device manufacturers deserve much of the credit for the increased quality of life for patients; third-party labs such as ATS help manufacturers develop products that are eligible for sale in national and international marketplaces and ensure that the products designs don’t pose any significant risks to end users.
What is Orthopedic Device Approval Testing?
Much like all medical devices, orthopedic devices must undergo evaluations and tests where professionals and agencies such as the FDA determine if a product is reasonably safe. These tests may range from biocompatibility tests that assess how the human body responds to the material to mechanical tests that determine the amount of stress and movement the product can withstand without failing. The type of testing required varies with the type of product and the product’s safety risk classification. For example, a Class 1 medical device undergoes less strict testing parameters than a Class 3 device because the Class 3 device is high-risk and therefore essential to the health and life of the patient.
About Our Orthopedic Device Approval Testing
Our state-of-the-art medical device testing lab assists manufacturers in designing and testing their medical products to produce reliable and safe products that can succeed on the market. Our relationship with the FDA helps us stay to date with new regulations and regulations, ensuring that our clients’ products keep pace with the ever-evolving medical device market. Our medical device testing experts offer an extensive list of services that comply with standards issued by the FDA, ISO, and ASTM. In addition to our orthopedic device testing services, we offer the following:
- Prosthetic testing services
- Medical device compliance testing
- Spinal implant testing
- Medical device regulatory consulting services
Contact Us
Please complete an online request form or call +1 (888) 287-5227 to learn more about our testing and consulting capabilities.
Request Form
Medical Device Testing
ASTM Testing
- ASTM F1044 Shear Testing of CaP and Metallic Coatings
- ASTM F1160 Shear and Bending Fatigue of Coatings
- ASTM F1233
- ASTM F1264 Intramedullary Fixation Device Testing
- ASTM F1357 Articulating Total Wrist Implant Testing
- ASTM F1378 Shoulder Prostheses Testing
- ASTM F1541 ESFD Testing
- ASTM F1672 Patellar Prosthesis Testing
- ASTM F1714 Gravimetric Wear Assessment of Prosthetic Hip Design in Simulator Device Testing
- ASTM F1717 Spinal Implant Testing
- ASTM F1781 Elastomeric Flexible Hinge Finger Total Joint Implants Testing
- ASTM F1798 Spinal Implant Subassembly Testing
- ASTM F1820 Modular Acetabular Device Strength Testing
- ASTM F1829 Glenoid Locking Mechanism Shear Testing
- ASTM F1875 Fretting Corrosion Testing of Hip Implant Interfaces
- ASTM 2009 Modular Prostheses Taper Connection Testing
- ASTM F2025 Wear Assessment of Polymeric Components
- ASTM F2028 Glenoid Loosening Testing
- ASTM F2077 Intervertebral Body Fusion Device Testing
- ASTM F2183 Small Punch Testing
- ASTM F2193 Spinal Fixation Components
- ASTM F2267 Measuring Subsidence of Intervertebral Fusion Devices
- ASTM F2346 Standard and Dynamic Testing of Artificial Intervertebral Discs
- ASTM F2423 Wear and Fatigue Testing of Total Disc Prostheses
- ASTM F2502 Absorbable Plate and Screw Testing
- ASTM F2554 CAS System Precision Testing
- ASTM F2624 Static, Dynamic, and Wear Testing of Extra-Discal Spinal Implants
- ASTM F2624 Spinal Implant Dynamic Testing
- ASTM F2694 Lumbar Total Facet Prosthesis Testing
- ASTM F2706 Spinal Implant Fatigue Testing
- ASTM F2789 Mechanical and Functional Characterization of Nucleus Devices
- ASTM F2790 Static and Dynamic Testing of Total Facet Prostheses
- ASTM F382 Metallic Bone Plates Testing
- ASTM F384 Angled Orthopedic Fixation Testing
- ASTM F543 Metallic Medical Bone Screw Testing
- ASTM F564 Metallic Bone Staple Testing
ISO Testing
- Biocompatibility Testing for Medical Devices ISO 10993
- ISO-10328 Structural Testing of Lower Limb Prosthetics
- ISO 10993 Biocompatibility
- ISO 10993 Biocompatibility Testing
- ISO 10993 Testing
- ISO 10993 Testing Lab
- ISO 18192-1 Wear Testing for Intervertebral Disc Prostheses
- ISO 12189 Fatigue Testing of Flexible Spinal Implants
Medical Device Testing
- Fatigue Testing Lab
- Implant Testing
- Material Testing Laboratory
- Material Device Regulatory Compliance Testing
- Medical Device Testing
- Medical Device Testing Certification
- Medical Device Materials Testing
- Medical Device Materials Testing Consulting
- Medical Device Mechanical Testing
- Medical Device Mechanical Testing Regulations
- Medical Device Performance Testing
- Medical Device Product Testing
- Medical Device Reliability Testing
- Medical Device Standards Testing
- Medical Device Standards Testing Certifications
- Medical Device Testing Companies
- Medical Device Testing Services
- Medical Device Testing Lab
- Medical Implant Testing Lab
- Orthopedic Device Approval Testing
- Orthopedic Device Testing
- Prosthetic Testing
- Prosthetic Testing Services
- Prosthetic Testing Services
- Spinal Implant Testing